Risk analysis and control summary: The device master file should contain a summary of the risks identified during the risk analysis process and a description of how these risks have been controlled to an acceptable level. Preferably, this risk analysis should be based on recognised standards and be part of the manufacturer's risk management plan.The summary should address possible hazards for the in vitro diagnostic medical device such as the risk from false positive or false negative results, indirect risks which may result from in vitro diagnostic medical device associated hazards, such as instability, which could lead to erroneous results, or from user-related hazards, such as reagents containing infectious agents. The results of the risk analysis should provide a conclusion with evidence that remaining risks are acceptable when compared to the benefits. 5.0 Design and manufacturing information: 5.1 Device design: The Device master file should contain information to allow a reviewer to obtain a general understanding of the design applied to the in vitro diagnostic medical device. It should include a description of the critical ingredients of an assay such as antibodies, antigens, enzymes and nucleic acid primers provided or recommended for use with the in vitro diagnostic medical device. This section is not intended to take the place of the more detailed information required for a QMS audit or other conformity assessment activity. If design takes place at multiple sites, a controlling site must be identified.